Operations Manager

We are seeking a strategic, customer-focused Operations Leader to lead and optimize our manufacturing operations. This role is responsible for end-to-end plant execution, including Production, Manufacturing Engineering, Quality, and Maintenance.

As a key member of the Senior Leadership Team, this individual will contribute to business strategy, budgeting, and operational planning, while driving daily execution and performance.

The ideal candidate brings a strong foundation in engineering and quality, along with proven experience in regulated manufacturing environments. This leader will play a critical role in New Product Introduction (NPI), validation, and transfer of business, including the launch of new products and integration of equipment and processes from sister sites.

This individual is a highly collaborative and people-focused leader, capable of engaging with customers, aligning cross-functional teams, and building a strong, accountable culture.

Key Responsibilities

Strategic & Leadership Team Contribution

• Serve as a key member of the Senior Leadership Team, contributing to:




• Business strategy and long-term planning


• Annual operating plans and goal deployment


• Organizational design and capability building




• Provide leadership in budget development, cost management, and operational forecasting


• Demonstrate strong P&L awareness, aligning operational decisions with financial performance

Operational Leadership

• Lead plant operations across Safety, Quality, Delivery, Cost, and People (SQDCP)


• Drive execution through structured daily management systems and KPIs


• Build a culture of accountability, collaboration, and continuous improvement


• Ensure alignment between operational performance and customer expectations

Customer Engagement & Cross-Functional Collaboration

• Act as a key operations-facing leader for customers, supporting:




• Business reviews, technical discussions, and site visits


• Escalations and issue resolution




• Partner closely with Customer Service and Planning to:




• Align demand, capacity, and production schedules


• Communicate risks and ensure delivery commitments




• Collaborate with Program Managers, Engineering, and Quality to ensure seamless execution

Production & Manufacturing Execution

• Lead production through Production Managers and Shift Supervisors


• Ensure delivery of production targets with focus on efficiency, throughput, and schedule attainment


• Optimize performance in a high-volume, labor-intensive environment


• Drive improvements in OEE, capacity, and operational flow

Engineering, NPI & Validation

• Lead Manufacturing Engineering and provide strong technical leadership to operations


• Partner with NPI teams and Program Managers to:




• Support product development and transfer into manufacturing


• Ensure Design for Manufacturability (DFM)


• Execute and sustain process validation (IQ/OQ/PQ)




• Ensure successful launch of new products and processes, meeting quality, cost, and delivery expectations

Transfer of Business & Capacity Expansion

• Lead and support transfer of products, processes, and equipment from sister sites


• Oversee installation, qualification, and ramp-up of new machines and technologies


• Ensure smooth transitions with minimal disruption to customer delivery and quality performance


• Align resources, training, and process readiness to support capacity expansion

Quality & Regulatory Compliance

• Ensure compliance with ISO 13485 and applicable medical device regulations


• Partner with Quality to:




• Drive effective CAPA and root cause analysis


• Reduce defects, scrap, and customer complaints


• Maintain audit readiness and successful inspections




• Promote a proactive quality culture across operations

Maintenance & Equipment Reliability

• Oversee preventive and predictive maintenance programs


• Ensure high levels of equipment uptime and reliability


• Drive improvements in downtime reduction and asset utilization


• Support capital investment planning and execution

Continuous Improvement

• Lead Lean and Six Sigma initiatives across the plant


• Drive measurable improvements in:




• Throughput and cycle time


• Cost reduction


• Waste elimination




• Establish a culture of structured problem-solving and operational excellence

People Leadership & Culture

• Lead, coach, and develop teams including:




• Production leadership


• Manufacturing Engineering


• Maintenance leadership




• Build a people-first, high-performance culture focused on:




• Engagement and accountability


• Leadership development and succession planning




• Partner with HR to strengthen organizational capability and culture

Financial & Operational Performance

• Develop and manage plant budgets and cost performance


• Drive cost improvement initiatives and operational efficiency


• Utilize KPIs and data analytics to support business decision-making


• Align operational execution with financial goals and performance targets

Qualifications

Education

• Bachelor's degree in Engineering


• Advanced degree (MBA or MS) is a plus

Experience10+ years of leadership experience in manufacturing operations

• Proven experience leading multi-functional teams (Production, Engineering, Quality, Maintenance)


• Strong experience with:




• New Product Introduction (NPI)


• Process validation (IQ/OQ/PQ)


• Transfer of business and equipment between sites




• Experience in medical device manufacturing strongly preferred


• Injection molding experience preferred

Technical & Leadership Skills

• Strong expertise in:




• Manufacturing Engineering and process development


• Validation methodologies


• Quality systems and regulatory compliance




• Deep understanding of ISO 13485


• Experience with Lean Manufacturing / Six Sigma


• Strong financial acumen with P&L awareness


• Excellent communication skills with the ability to engage customers and internal stakeholders

• Strategic & Financial Acumen


• Technical & Operational Leadership


• NPI & Product Launch Execution